Hospital-to-home support for children and youth with special health care needs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study assigns hospitalized children and youth with special health care needs and their adult caregivers to either a focused-dose transitional care intervention (one post-discharge phone call) or an extended-dose intervention (weekly phone calls for one month). Primary outcomes are health service use (e.g., emergency visits, readmissions) and parent-reported confidence in managing the child's care at home. The trial includes subgroup analyses for clinically complex and racially/ethnically vulnerable children and uses EHR data plus caregiver reports for outcome measurement. A parallel mixed-methods implementation evaluation will examine context, processes, and mechanisms affecting delivery and impact.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For this study, eligible children/youth with special health care needs (CYSHCN) and adult parent/caregiver dyads will be those who meet the following inclusion criteria:

  1. Child is a CYSHCN, defined as having seen two or more distinct specialty areas for outpatient visits during the 12 months prior to index hospitalization admission date
  2. Age of hospitalized child is under 18 years old
  3. Child hospitalized on a general pediatrics inpatient service line at participating site
  4. Adult parent/caregiver for the child is 18 years or older

Exclusion Criteria:

* Child exclusion criteria:

  1. Child will be discharged to any location besides home (e.g., long-term care or residential facility, skilled nursing facility, inpatient acute rehabilitation, psychiatric facility)
  2. Child is a ward of the state or has an ongoing social services investigation
  3. Child is already receiving transitional care, intensive longitudinal care coordination (e.g., organ/disease-specific clinical program, clinical division within the same institution as the hospital \[e.g., Children's Complex Care Program at UNC; Complex Care Service at Duke\]), and/or longitudinal population health care coordination as part of a bundled alternative payment care model.
* Parent/caregiver exclusion criteria include:

  1. Age less than 18 years old
  2. Diminished capacity to provide consent/participate
  3. Primary language for parent/caregiver is any language besides English or Spanish

Where it's running

• UNC Hospitals
  Chapel Hill, North Carolina, United States Recruiting
• Duhs
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: David Ming, MD — Duke University
• Study coordinator: Jennifer Thomas, MPH
• Email: jennifer.thomas@duke.edu
• Phone: (919) 613-5953

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.